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. 2018 Apr 24;2018(4):CD008581. doi: 10.1002/14651858.CD008581.pub2

Butterworth 1971a.

Methods Randomized, double‐blind, comparative trial
Participants 39 people with alcohol dependence (all men; mean age: information not available) with a significant degree of anxious‐depressive symptomatology.
Inclusion criteria:
  • aged 20‐55 years

  • significant degree of anxiety and depression as determined by psychiatric interview

  • current diagnosis of alcohol dependence


Exclusion criteria:
  • physical brain

  • liver illnesses

  • psychotic disorder


Participants with bipolar disorder: information not available
Interventions Drugs:
  • doxepin (75 mg/day; 20 participants, all men; mean age: 45 years)

  • diazepam (15 mg/day; 19 participants, all men; mean age: 41 years)


Psychotherapy: information not available
Scheduled duration of treatment: 3 weeks
Site: Alcoholism Treatment Service of East Louisiana State Hospital, Mandeville, LA, USA
Setting: inpatients
Route of administration: orally
Starting dose: information not available
Pattern of dose reduction: information not available
Outcomes Depression:
  • final BPRS score

  • final ZUNG score

  • response


Alcohol dependence: data not available
Dropouts
Adverse effects
Notes Baseline characteristics of participants
Depression:
  • primary depression: information not available

  • duration: information not available

  • BPRS score (mean): doxepin = 76.3; diazepam = 73.8

  • ZUNG score (mean): doxepin = 47.8; diazepam = 37.9


Alcohol dependence:
  • severity: information not available

  • being actively drinking: participants not actively drinking


Other psychiatric comorbidity: information not available
Other substance‐use disorders: information not available
Other characteristics of study
Other pharmacological treatment: other concomitant therapy not allowed
Funding source: medications were supplied by Laboratories of Pfizer Inc.
Declaration of interest: information not available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random allocation stated. No further details provided.
Allocation concealment (selection bias) Unclear risk Method of concealment not described.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind stated. Medications prepared to appear identical. Evaluations conducted by 2 independent investigators and the results pooled.
Blinding of outcome assessment (detection bias) objective Low risk No information on blinding of outcome assessors.
Blinding of outcome assessment (detection bias) subjective Unclear risk No information on blinding of outcome assessors.
Incomplete outcome data (attrition bias) 
 All outcomes High risk No information on dropouts provided. Methods applied to account for missing data not described. Intention‐to‐treat approach not reported.
Selective reporting (reporting bias) High risk No information on dropouts provided. Methods applied to account for missing data not described. Intention‐to‐treat approach not reported.